The Role
The post will be based at the John Walton Muscular Dystrophy Research Centre (JWMDRC) at Newcastle University. The post will provide an opportunity for the successful candidate to build on experience of data management in clinical research to demonstrate leadership skills in this large international study focussing on quality assurance and data analysis.
The post holder will play a key role in coordination of a large international natural history study for Dysferlinopathy (The Jain COS Study) and smaller local sister study (COS PrePARED) and contribute to the development of new projects that are related to the Jain COS study. The post holder will also be tasked with identifying opportunities for collaboration with other internal and external projects, lead the integration from different sources and different types of data validation of the clinical databases. They will be the main point of contact and monitor for the international sites with protocol and data queries.
The postholder will have experience of data management and standard statistical analysis and may be looking for an opportunity to specialize in specific disease area. They will also have opportunities to develop their own analysis skills by supporting the multidisciplinary analysis teams, working closely with and supported by the study statistical lead Dr Heather Gordish based at Children’s National Hospital in Washington DC, a world-renowned statistician in the Neuromuscular Field. We envisage that interested successful candidates may have the opportunity to register for a PhD.
Key Accountabilities
Develop and maintain data collection tools and instruments and work with the external data manager to adjust them to fit the needs of the project as it develops
Lead for data quality assurance at site monitoring visits, including source data verification. Complete site file monitoring according to Sponsor guidance
Issue appropriate feedback on areas for improvement and oversee the implementation of any recommended actions following audit
Work closely with the Study PI and steering group in contributing to the design of data collection forms for the Jain COS Study and other Limb Girlde Muscular Dystrophy (LGMD) studies
Oversee the collection and collation of data collection forms from participating centres and ensure the input of this data onto computerised databases as needed
Work closely with the study manager to ensure completion of regular and timely data cleaning procedures, and quality controls to ensure that all trial data is accurate, complete and timely, identifying and following up any data omissions or queries, identifying potential problems and taking appropriate action
Develop good working relationships with collaborating sites to ensure responses to data queries are received in a timely fashion
Prepare data for analysis and perform statistical analysis. Contribute to peer reviewed publications using this analysis
Prepare data management plans and ensure accurate and thorough documentation of all data management activities in accordance with applicable legislation and current standard operating procedures
Provide data to the Trial Management Group to facilitate the preparation of progress reports for Funders, Trial Steering Committees, Independent Data Monitoring and Ethics Committees, and other bodies, performing basic descriptive analyses of data, and presenting results in a format suitable for reporting
Assist in the preparation of data and materials for publication and/or presentation at scientific meetings or in scientific journals
Give presentations and provide training on the effective use of data capture systems including development of trial specific user manuals internationally through the Jain COS Consortium
Ensure studies are conducted in accordance with GCP (Good Clincal Practice) and other applicable legislation for Clinical Trials, and the General Data Protection Regulation
Contribute to, and lead on, writing and reviewing of JWMDRC SOPs and policy documents on data collection and management systems and processes, including the review of quality improvement and other related initiatives
Be able to plan and organise own workload and supervise that of others when required
Use initiative while being aware of circumstances which require the involvement of CI’s, PI’s trial statisticians and trial managers.
Work with Investigators and the wider research team in planning data collection systems and data management
Attend internal and external meetings as the expert in database and data management and develop close and effective working relationships with CI’s, PI’s, statisticians, health economists, other specialists and the trial management team
Complete a data management risk assessment for the Jain COS Consortium.
Further develop the data access policies and processes for the Jain COS consortium. Work with the JWMDRC to audit data access policies across JWMDRC led clinical research projects
Within the JWMDRC identify and assess commonalities in data sets between the COS Studies and other relevant John Walton Muscle projects including patient registries, to support the wider work of the Chief Investigator and increase academic output. Work locally within the JWMDRC to support the development and coordination of robust data quality management processes including preparation of standard operating procedures to ensure research data validity
Liaise with other external researchers / partners working on related projects external to the JWMDRC E.g. C-Path LGMD Taskforce.
Liaise with academic and industrial partners who are interested in accessing study data to understand their needs develop appropriate data requests for consideration by the study steering committee
Any other duties, appropriate to the grade, which may be required from time to time by the JWMDRC
The Person
Knowledge, Skills and Experience
Knowledge of good data management principles
Evidence of ability to set up, maintain and manage an effective research data management system, which produces reports and raises queries e.g. web-based CRF
Working knowledge of regulatory and governance requirements for clinical research studies in the UK
Experience of database design
Experience of data management, data checking, data cleaning and reporting
An understanding of the requirement of data protection regulations, the need for confidentiality and the ability to work to these
High levels of literacy and numeracy
Excellent IT skills including the use of the Microsoft Office Package
Ability to prioritise and manage workload using your initiative as required
Ability to make independent decisions and to work independently, alongside excellent team working skills
Appropriately handle confidential and sensitive information
Excellent organisational and administrative skills
Desirable
Knowledge and hands-on experience of statistical software
Knowledge and hands-on experience of SQL programming
Knowledge and hands-on experience of Clinical Data Management Systems (e.g. Open Clinica, REDCAP etc )
Knowledge of Clinical Research Methodology and Monitoring processes including source data verification
Experience of working on clinical research studies
Experience of working in a University or NHS environment
An understanding of data collection in an NHS environment
Attributes and Behaviour
Excellent interpersonal skills
Excellent attention to detail
Excellent communication skills
Flexible approach to working
Willingness to travel to trial sites and to trial meetings as required
Qualifications
Degree in a relevant subject (or equivalent relevant experience in a senior role) This could include scientific, medical, communications, languages, maths or data science degrees
Desirable
Higher degree in a relevant subject
Newcastle University is a global University where everyone is treated with dignity and respect. As a University of Sanctuary, we aim to provide a welcoming place of safety for all, offering opportunities to people fleeing violence and persecution.
We are committed to being a fully inclusive university which actively recruits, supports and retains colleagues from all sectors of society. We value diversity as well as celebrate, support and thrive on the contributions of all of our employees and the communities they represent. We are proud to be an equal opportunities employer and encourage applications from individuals who can complement our existing teams, we believe that success is built on having teams whose backgrounds and experiences reflect the diversity of our university and student population.
At Newcastle University we hold a silver award in recognition of our good employment practices for the advancement of gender equality. We also hold a Bronze award in recognition of our work towards tackling race inequality in higher education REC. We are a employer and will offer an interview to disabled applicants who meet the essential criteria for the role as part of the offer and interview scheme.
In addition, we are a member of the Euraxess initiative supporting researchers in Europe.
Requisition ID: 28378
